Careers-Shenzhen Sungening Biological Co., Ltd

a. Responsible for guiding the quality research including the method development, verification, release and stability research, and establishing drugs specification.
b. Responsible for the drafting and reviewing of various documents for the project, and dealing with the deviation.
c. Responsible for writing and reviewing the application documents and original records, which can accurately and clarify the content of quality research to meets the application requirements of the drug regulatory bureau then complete the drug listing.
d. Responsible for retrieval Chinese and English literature, follow the latest domestic and foreign updating of research progress and regulations of each Agency.
e. Arrange the assignment of each project reasonably, face and resolve the problems to ensure the smooth progress of each project.
f. Responsible for daily management of the laboratory, training of analysts, and etc.
g. Other work assigned by leader.

a. Pharmaceutical medicine, pharmacy or related major. Master’s/Doctor’s degree or above, more than 2 years of R&D working experience.
b. Familiar with cGMP, ICH and FDA related research guidelines, Familiar with domestic and international registration declaration and review requirements.
c. Proficiency in analytical instruments such as the moisture meter, dissolution tester, HPLC, LC-MS, ability to develop and verify methods independently.
d. Proficiency in the technologies of formulated drugs. Experience for biological and chemical formulation prescriptions, preclinical testing agent development, formulation process research, and process amplification.
e. Be able to retrieve and review professional literature, have a certain level of English writing, can draft English documents.
f. With strong capabilities of time management, execution and multiple projects planned at the same time.

Careers